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艾附暖宫软胶囊制备工艺研究 |
王健1, 张壮丽2, 杨海燕1, 李逢春1, 朱潇潇3, 顾宁宁3, 吴娟3, 张兴德3
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1.河南省食品药品检验所, 郑州 450018;2.河南省医药科学研究院, 郑州 450052;3.南京中医药大学, 南京 210023
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摘要: |
[目的]对艾附暖宫软胶囊制备工艺进行优选。[方法]以流动性、均匀性和沉降体积比为考察指标,在单因素实验基础上,利用响应面软件Box-Behnken设计模型确定内容物的最佳工艺处方;以胶皮韧性和胶液黏性为指标,优化软胶囊囊皮处方;考察制备工艺,确定工艺参数。[结果]确定大豆油为分散介质,浸膏粉、大豆油、蜂蜡比例为1∶2.2∶6.25%,膏粉粒度为120目,制得的内容物混悬效果最好,以明胶、甘油、水比例为1∶0.4∶1的比例制备的囊皮效果最佳,胶盒温度50~60℃、喷体温度35~37℃,制冷温度为16~18℃,胶囊成形率和得率最高。[结论]优选的制备工艺合理,制剂稳定。 |
关键词: 艾附暖宫软胶囊 制备工艺 响应面 |
DOI:10.11656/j.issn.1672-1519.2018.10.17 |
分类号:R944.5 |
基金项目:河南省科技攻关项目(152102310131)。 |
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Study on preparation technology of Aifu Nuangong soft capsule |
WANG Jian1, ZHANG Zhuangli2, YANG Haiyan1, LI Fengchun1, ZHU Xiaoxiao3, GU Ningning3, WU Juan3, ZHANG Xingde3
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1.Henan food and Drug Inspection Institute, Zhengzhou 450018, China;2.Henan Academy of Medical Sciences, Zhengzhou 450052, China;3.Nanjing University of Chinese Medicine, Nanjing 210023, China
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Abstract: |
[Objective] To optimize the preparation of AIfu Nuangong soft capsule.[Methods] On the basis of single factor experiment,with fluidity, uniformity and settlement volume ratio as index, the optimal process conditions were determined by Box-Behnken design as follows; the quality of capsule shells depending on the adhesive toughness and viscosity.[Results] Soybean oil is a good dispersing medium, and the ratio between drug soybean oil and beeswax is 1:2.2:6.25% can make sure the suspension system is best, and the best prescription of capsule shells was gelatin:glycerol:water=1:0.4:1. besides when the temperature of box is between 50~60℃,the temperature of the spray body is 35~37℃, and the cooling temperature is 16~18℃, the capsule is best.[Conclusion] The preparation process parameters are reasonable and the preparation is stable. |
Key words: Aifu Nuangong soft capsule preparation technology response surface methodology |